|Publication number||US7241259 B2|
|Application number||US 10/699,989|
|Publication date||Jul 10, 2007|
|Filing date||Nov 3, 2003|
|Priority date||Apr 30, 1999|
|Also published as||CA2372204A1, DE60018566D1, DE60018566T2, EP1191902A1, EP1191902A4, EP1191902B1, US6676593, US20010041822, US20040097786, US20080015548, WO2000066054A1|
|Publication number||10699989, 699989, US 7241259 B2, US 7241259B2, US-B2-7241259, US7241259 B2, US7241259B2|
|Inventors||Valery Migachyov, Tu T. Pham|
|Original Assignee||Feelsure Health Corporation|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (39), Referenced by (1), Classifications (5), Legal Events (4)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation of U.S. patent application Ser. No. 09/908,467, filed on Jul. 18, 2001, now U.S. Pat. No. 6,676,593, which in turn is a continuation of U.S. patent application Ser. No. 09/302,856, filed on Apr. 30, 1999, now abandoned.
The present invention relates generally to devices and methods for treating female urinary incontinence. More particularly, the present invention relates to intraurethral devices and methods for controlling urine flow.
Female urinary incontinence is a common medical condition, having widespread economic and social ramifications. The difficulty and embarrassment associated with urinary incontinence often causes the affected person to limit her social activities. In some cases, pads or diapers are used to absorb the uncontrolled seepage of urine. These absorbent items must be changed frequently, creating an ongoing economic burden. The wearing of absorbent undergarments may also restrict the type or style of clothing which the patient may wear. More seriously, skin irritation and other hygienic difficulties often result from the lingering presence of captured urine against tender urogenital tissues.
An additional method of treating urinary incontinence is the use of bladder flow control devices, sometimes referred to as artificial sphincters or prosthetic urethral valves. A bladder flow control device may be positioned in the. urethra of a patient to control the flow of urine out of the bladder. It is desirable for the placement of the bladder flow control apparatus in the urethra to be performed easily and non-surgically. Once the bladder flow control device is placed, it is desirable that it be safely and securely retained in the urethra. Optimally, the device surfaces which contact the human body. will be formed of biocompatible materials, to lessen chances of inflammation in patients.
The present invention relates generally to devices and methods for treating female urinary incontinence. More particularly, the present invention relates to an intraurethral device including a sheath having a distal portion and a proximal portion. The sheath includes a proximal retainer disposed proximate its proximal end. The proximal retainer serves to prevent distal motion of the sheath into the patient by lying against the urethral labia. The sheath further includes a sheath wall defining a central lumen. A flow control valve unit is disposed in the lumen of the sheath.
An intraurethral device in accordance with the present invention, further includes a distal member having a distal tip and a proximal portion. The proximal portion of the distal member is fixed to the distal portion of the sheath by a linking means. In one embodiment of the present invention, the linking means includes an elastomer hinge. When the elastomer hinge is in a natural, undeformed state, the central axis of the distal member of the intraurethral device is positioned at an angle to the central axis of the sheath. The distal member of the intraurethral device may be urged into axial alignment with the sheath by deforming the elastomer hinge.
In a presently preferred method in accordance with the present invention, the distal member is urged into axial alignment with the sheath during insertion of the intraurethral device into the urethra of a patient. In this presently preferred method, the intraurethral device is inserted into the urethra of the patient until the distal member is free to assume a misaligned position. In this misaligned position, the elastomer hinge assumes its natural, undeformed state. When the distal member of the intraurethal device assumes this misaligned position, the distal member serves to prevent proximal motion of the sheath out of the patient by contacting the bladder floor. Distal motion of the sheath into the patient is prohibited by the proximal retainer disposed at the proximal end of the sheath. In this manner, the intraurethral device is held within the urethra by the distal member and the proximal retainer acting at opposite ends of the urethra.
An insertion tool is also provided. The insertion tool includes a shaft having a distal end and a proximal end. The distal end of the shaft is adapted to selectively form a connection with a proximal end of the flow control valve unit disposed in the lumen of the sheath. The shaft of the insertion tool provides a convenient location to grasp the assembly. The use of an insertion tool minimizes the risk of infection by minimizing human contact with the intraurethral device.
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention.
Examples of constructions, materials, dimensions, and manufacturing processes are provided for selected elements. All other elements employ that which is known to those of skill in the field of the invention. Those skilled in the art will recognize that many of the examples provided have suitable alternatives which may be utilized.
A flow control valve unit 40 is disposed in lumen 30 of sheath 22. Two examples of flow control valve assemblies which are suitable for inclusion in valve housing 40 are described by Kulisz et al. in U.S. Pat. No. 5,437,604 entitled NONSURGICAL INTRAURETHRAL BLADDER CONTROL DEVICE, and U.S. patent application Ser. No. 09/207,821 by Migachyov and entitled VALVE FOR BLADDER CONTROL DEVICE, the disclosure of each being hereby incorporated by reference. Those of skill in the art will appreciate that other flow control valves may be used in conjunction with. intraurethral device 20 without departing from the spirit or scope of the present invention.
Proximal region 24 of sheath 22 includes a proximal lock 42 having recesses or cavities 44. Recesses 44 are adapted to receive a flange portion 48 of flow control valve unit 40. A distal stop 46 lies in distal region 26 of sheath 22 for arresting the distal movement of flow control valve unit 40. Sheath walls 32 are preferably formed of an elastomeric material such that a tubular flow control valve unit inserted within lumen 30 is partially held in position by a friction fit between the elastically stretched sheath walls 32 and the outside walls of the inserted flow control valve and/or by a medical grade adhesive.
Intraurethral device 20 also includes a distal member 50 having a distal tip 52 and a proximal portion 54. Proximal portion 54 of distal member 50 is fixed to distal portion 26 of sheath 22 by a linking means 60. In the embodiment of
When no external force is applied to elastomer hinge 62, intraurethral device 20 assumes the position illustrated in
In a presently preferred embodiment, sheath 22, distal member 50, and elastomer hinge 62 are all comprised of the same material. A presently prefer-red method of manufacturing this preferred embodiment is injection molding. Materials which may be suitable for this preferred embodiment include implantable grade silicone rubber, and thermoplastic rubber. Single piece construction simplifies assembly and reduces the possibility of any device components separating during residence in the patient
Embodiments of intraurethral device 20 have also been envisioned which include a surface layer 90. Surface layer 90 may include an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use. Surface layer 90 may also include materials such as hyaluronic acid, a hydrogel, or other materials to mimic mucous. Surface layer 90 may also include a lubricious material such as a hydrophilic hydrogel or a hydrophobic silicone to facilitate insertion and removal. It is envisioned that one or more of the above described surface layer materials can be used. Embodiments of intraurethral device 20 have also been envisioned having a distal member 50 and a sheath 22 which are comprised of a material which includes the materials described above.
In a presently preferred method distal member 50 is urged into position 100 when inserting sheath 22 into the urethra. This method may now be described with reference to
A presently preferred method in accordance with the present invention begins with the step of inserting distal member 50 into a female urethra. Intraurethral device 20 is then urged into position 100 as shown in
Proximal portion 54 of distal member 50 is fixed to distal portion 26 of sheath 22 by a linking means 60. In the embodiment of
A method of positioning an intraurethral device 20 into a urethra using insertion tool 400 may now be described with reference to
Having placed intraurethral device 20 into the urethra, insertion tool 400 may now be removed from lumen 30 of sheath 22. This may be accomplished by applying a pulling force on shaft 402 of insertion tool 400 while applying a pushing force on proximal retainer 28 of intraurethral device 20. When insertion tool 400 is removed, distal portion 50 of intraurethral device 20 will be free to assume position 200 as shown in
With sheath 22 and distal member 50 now in the desired position, flow control Valve unit 40 may now be inserted into lumen 30 of sheath 22. One method suitable for inserting a flow control valve unit into a sheath is described by Pham in U.S. Pat. No. 5,871,016 entitled BLADDER CONTROL DEVICE RETAINER AND METHOD, the disclosure of which is hereby incorporated by reference. This U.S. patent is commonly assigned with the present application.
In the foregoing method, shaft 402 of insertion tool 400 provides a convenient location to grasp with the fingers. The use of insertion tool 400 minimizes the risk of infection by minimizing human contact with intraurethral device 20.
Other embodiments of insertion tool 400 are possible without deviating from the spirit or scope of the present invention. Specifically, in a presently preferred embodiment, distal end 404 of shaft 402 is adapted to releasably mate with the proximal end of flow control valve unit 40. A method of inserting an intraurethral device 20 in a urethra utilizing this presently preferred embodiment of insertion tool 400 may now be described with reference to
When flow control valve 40 is inserted completely into lumen 30 of sheath 22, flange 48 may be inserted into recesses 44. With the distal end of insertion tool 400 mated to the proximal end of flow control valve unit 40, shaft 402 of insertion tool 400 provides a convenient location to grasp the assembly. The use of insertion tool 400 minimizes the risk of infection by minimizing human contact with intraurethral device 20.
Shaft 402 of insertion tool 400 may be grasped with the physicians fingers to begin insertion of intraurethral device 20 is inserted into the urethra. Distal member 50 of intraurethral device 20 may then be inserted into the urethra of the patient. Having positioned distal member 50 in the urethra, intraurethral device 20 is then urged into position 100 as shown in
Once intraurethral device 20 is located in the desired position, the distal end of insertion tool 400 may be disengaged from the proximal end of flow control valve unit 40. Those of skill in the art will appreciate that a number of methods may be used to releasably mate distal end 404 of shaft 402 to the proximal end of the flow control valve unit 40. Examples of methods suitable for some applications include screw threads, a bayonet connection, and an interference fit.
A flow control valve unit 140 is disposed in lumen 130 of sheath 122. Proximal region 124 includes a proximal lock 142 having recesses or cavities 144. Recesses 144 are adapted to receive a flange portion 148 of flow control valve unit 140. A distal stop 146 lies in distal region 126 for arresting the distal movement of flow control valve unit 140. Sheath walls 132 are preferably formed of an elastomeric material such that a tubular flow control valve unit inserted within lumen 130 is partially held in position by a friction fit between the elastically stretched sheath walls 132 and the outside walls of the inserted flow control valve.
Intraurethral device 120 also includes a distal member 150 having a distal tip 152 and a proximal portion 154. Proximal portion 154 of distal member 150 is fixed to distal portion 126 of sheath 122 by a linking means 160. In the embodiment of
Intraurethral device 120 assumes the position illustrated in
In a presently preferred embodiment, distal member 150 and leaf spring 500 are fixed together using an over molding process. In the manufacturing process, a distal portion of leaf spring 500 is positioned in a mold cavity. The material of distal member 150 is then injected into the mold cavity. The material of distal member 150 surrounds distal portion of leaf spring 500. Materials which may be suitable for this preferred embodiment include thermoset materials such as implantable grade silicone rubber. Materials which may be suitable for this preferred embodiment also include thermoplastic materials such as thermoplastic rubber. Those of skill in the art will appreciate that other methods of attaching distal portion 502 of leaf spring 500 to distal member 150 may be used without deviating from the spirit or scope of the present invention. For example, the mechanical attachment or the use of adhesives may be suitable for some applications.
In the embodiment of
When insertion tool 400 is removed, distal portion 150 of intraurethral device 120 will be free to assume position 200 as shown in
Referring now to
Having thus described the preferred embodiments of the present invention, those of skill in the art will readily appreciate that yet other embodiments may be made and used within the scope of the claims hereto attached.
Numerous advantages of the invention covered by this document have been set forth in the foregoing description. It will be understood, however, that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of parts without exceeding the scope of the invention. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
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|International Classification||A61M1/00, A61F2/00|
|Feb 7, 2006||AS||Assignment|
Owner name: FEELSURE HEALTH CORPORATION, ILLINOIS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:HK MEDICAL TECHNOLOGIES, INC.;REEL/FRAME:017125/0614
Effective date: 20040531
|Feb 14, 2011||REMI||Maintenance fee reminder mailed|
|Jul 10, 2011||LAPS||Lapse for failure to pay maintenance fees|
|Aug 30, 2011||FP||Expired due to failure to pay maintenance fee|
Effective date: 20100703